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Compares treatment options for Glaucoma
Official title A Trial of Hydrus Microstent Versus Goniotomy
ClinicalTrials.gov ID: NCT06289491
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are: How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- Visually significant cataract planned for surgery
- Mild to moderate open-angle glaucoma, including pigmentary glaucoma and pseudoexfoliation glaucoma
- Mild stage glaucoma includes glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB, with no points in the central 5...
- Moderate stage glaucoma includes: 1) glaucomatous optic neuropathy and visual field mean deviation equal to or worse than -6.0 dB but no worse than...
- Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery
You likely can't join if
- Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation
- Selective laser trabeculoplasty within 90 days of study enrollment
- Iridotrabecular contact for 180 degrees or greater
- Peripheral anterior synechiae in nasal or inferior angle
- Best corrected visual acuity worse than 20/200
- Phacodonesis on pre-operative examination
See the full eligibility criteria
- Visually significant cataract planned for surgery
- Mild to moderate open-angle glaucoma, including pigmentary glaucoma and pseudoexfoliation glaucoma
- Mild stage glaucoma includes glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB, with no points in the central 5 degrees \<15 dB
- Moderate stage glaucoma includes: 1) glaucomatous optic neuropathy and visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5 degree points \<15 dB or 2) mean deviation...
- Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery
- Willing and able to understand and provide informed consent
- Willing and able to attend postoperative examinations per protocol schedule
- Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation
- Selective laser trabeculoplasty within 90 days of study enrollment
- Iridotrabecular contact for 180 degrees or greater
- Peripheral anterior synechiae in nasal or inferior angle
- Best corrected visual acuity worse than 20/200
- Phacodonesis on pre-operative examination
- Vitreous in anterior chamber on pre-operative examination
- Nanophthalmos
- Anti-platelet and anticoagulant medications other than aspirin 81mg daily
- Active treatment for another ophthalmic condition in either eye (e.g., anti-VEGF injections, steroids for corneal transplant)
- Abnormality in study eye that could affect tonometry
- Glaucoma diagnosis other than the above
- Normal tension glaucoma
- Conditions that can cause elevated episcleral venous pressure (e.g., Sturge-Weber syndrome, Graves disease, retrobulbar tumor)
- History of uveitis in either eye
- Inability to complete gonioscopy examination
- Use of oral steroids within 90 days or anticipated use of oral steroids
- Oral medications that can affect IOP, including oral carbonic anhydrase inhibitors such as acetazolamide and methazolamide
- History of steroid-associated IOP elevation
- Medically unfit for attending planned study visits
- Involvement in another treatment research study
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.